A total of 270 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 2:1 with etomidate as the control group.Neither the investigators nor the subjects were aware of the group assignments. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. Compared with etomidate, the efficacy and safety of Methoxyethyl Etomidate Hydrochloride for sedation/anesthesia in gastroscopy/colonoscopy were further evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
The initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)
The initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)
Peking University First Hospital
Beijing, Beijing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Guangyuan First People's Hospital
Guangyuan, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Success rate of gastroscopy/colonoscopy
From the time of bolus administration to the completion of gastroscopy/colonoscopy, the following two conditions were met simultaneously: (1) the number of additional doses within any 15 minutes was ≤5; (2) no use of rescue drugs.
Time frame: Within approximately 1 hour after injection
Sedation/anesthesia success rate
Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Time frame: Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
The time from the first administration of the experimental drug to the MOAA/S score ≤1
Time frame: within approximately 1minute after injection
Duration from successful insertion to full consciousness
the time from successful insertion to full awakening (the first time of three consecutive MOAA/S scores reaching 5 points
Time frame: after approximately 30 minutes of the completion of the last injection
Duration from completion of experimental drug administration to full recovery
The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5
Time frame: Within approximately 50 minutes of the completion of the last injection
The time from the end of treatment to full consciousness
The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5
Time frame: Within approximately 60 minutes of the completion of the first injection
The time from the end of the endoscopic session to discharge from the room
The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9
Time frame: A maximum of 10 minutes after awakening
Rate of use of remedial drugs
Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more
Time frame: 60minutes after injection
Test drug additions
the additional situation and dosage of drugs were summarized
Time frame: 30minutes after injection
Assessment of orientation
Orientation was evaluated when MOAA/S reached 5 points for the first time after the complete withdrawal of gastroscopy/colonoscopy
Time frame: 20 minutes after the end of endoscopic treatment
Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated
The total score is 10, that is, a score of 0 indicates very dissatisfied and a score of 10 indicates very satisfied
Time frame: 60 minutes after the end of endoscopic treatment
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